Tongue SCC Clinical Trial
Official title:
Virtual Planning Of Anterolateral Thigh Free Flap for Reconstruction Of Hemiglossectomy
Verified date | June 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the advantage of using preoperative virtual planning to design the volume and shape of antero-lateral thigh free flap tissue transfer to reconstruct tongue defects resulted from carcinoma resection and see how this would affect tongue form and speech function.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with primary tongue squamous cell carcinoma (SCC) requiring hemi-glossectomy. 2. No alveolar ridge involvement by the tumor process. 3. Planned to undergo tongue reconstruction using ALTF. 4. Patients with a depth of invasion more than 10mm but not crossing midline according to the classification of Ansarin et. al., we perform type IIIA glossectomy. Exclusion Criteria: 1. Medically unfit patients; those who are not good candidates for long microvascular surgical reconstructive procedures e.g.: advanced Cardiopulmonary diseases. 2. Recurrent tongue carcinoma. 3. Patients with lesions invading the alveolar ridge. 4. Missing or non-compliance for imaging investigations. 5. Patients underwent preoperative adjuvant therapies. 6. No children will be involved in this study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Florida |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Prospectively evaluate a new method of virtually planned ALTF and changes in flap volume for the reconstruction of tongue defects following hemi-glossectomy | Investigators will preoperatively use CT measurements and virtual planning 3D software to calculate the required ALT flap volume /cm3 by measuring flap dimensions (height, width and length) /cm3 and compare it with the postoperative real outcomes by re-measuring the real flap dimensions ( height, width and length) /cm3 . | Changes in flap volume/cm3 will be measured after one and six months after surgery where the preoperative virtually planned volume/cm3 is being the base line. | |
Secondary | Assessment of Intelligibility of Dysarthric Speech (AIDS) test will be used to assess tongue speech functions following tongue reconstruction and compare speech changes. | - In the AIDS test the speech analysist examiner will randomly select two sentences (5-15 words) for a total of 22 sentences utilizing table in manual, and reads them aloud once and then allow patients to say them while audio records each session via voice app on phone.
Judge from the investigators will listen and transcribe. Making a report and develop outcomes. Scoring will be according the standard scores of the AIDS test analysis where: Intelligibility: Corresponds to number of correct words. Speaking rate: Corresponds to words per minute (WPM) / duration of sentence samples in minutes Rate of intelligible speech (intelligible words per minute (IWPM)): number of words identified correctly /total duration Rate of unintelligible (unintelligible words per minute (UWPM)): number of unintelligible/total duration Communication efficiency ratio: IWPM/190 IWPM. |
Changes of speech will be compared After one and six months after surgery where the preoperative speech will be the base line. |
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